Effect of West China Perioperative Transfusion Score (WCPTS) on Red Blood Cells Transfusion in Patients Undergoing Major Surgery: a Prospective, Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,351
- 试验地点
- 1
- 主要终点
- Proportion of patients received red-cell
研究概览
简要总结
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen, core temperature, and angina. To verify this hypothesis, the investigators present West China Perioperative Transfusion Score (WCPTS) for the trigger of transfusion according to the patient's history and monitoring parameters, and the investigators design a randomized controlled clinical trial to test this score.
详细描述
Surgery and trauma are the most common reasons for major blood loss, and blood transfusion provide guarantee for massive hemorrhagic surgery, especially orthopedic, cardiac, liver, and gynecologic procedures. On the other hand, blood transfusion is associated with many risks including hemolytic and nonhemolytic reactions, transfusion related acute lung injury (TRALI), and others. Besides, blood is insufficient worldwide. How to eliminate allogeneic blood transfusion is an important part in clinical practice.
Guidelines for blood transfusion have been issued for years. According to these guidelines, red blood cells (RBCs) transfusion should be given when the hemoglobin level is less than 6g/dL or 7g/dL and is unnecessary when the level is more than 10g/dL. However, in all the guidelines, the determination of whether RBCs should be administered when the hemoglobin level is in the range of 6~10g/dL is based on the judgment from anesthesiologists or surgeons. Index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL is necessary and important in clinical practice.
Based on the aim of blood transfusion that maintain the balance of oxygen supply and oxygen consumption, the investigators hypothesize that index of transfusion trigger for patients with hemoglobin level between 6g/dL and 10g/dL could be calculated by parameters including infusion rate of adrenalin for maintaining normal cardiac output, fraction of inspired oxygen for maintaining spO2≧95%, core temperature, and angina.
Peri-Operative Transfusion Trigger Score, POTTS The initial score is 6. If a patient's cardiac output is normal without infusion of adrenalin, his spO2 could be maintained more than 95% with FiO2≤35%, his core temperature is less than 38℃, and he has no angina, his score is 6.
If a patient has one or more problems, including his normal cardiac output should be maintained by infusion of adrenalin with its rate ≤0.05μg/kg.min, or his spO2 is maintained more than 95% with 36~50% FiO2, or his core temperature is between 38℃ to 40℃, or chest pain due to exercise,manual labor,or excitement, his score should be added 1 point for each problem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 14 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Height of usual place of residence less than 2,500 metres above sea level
- •Perioperative hemoglobin level possibly less than 10g/dL
排除标准
- •Emergency operation
- •ASA classification V or VI
- •Serious blood system diseases
- •Dysfunction of hemoglobin
- •Hypervolemic hemodilution
- •Tumor metastasis
- •Psychopathy
- •Refuse to sign consent
结局指标
主要结局
Proportion of patients received red-cell
时间窗: Up to 30 days postoperatively
Proportion of patients received red-cell during peri-operative period
Composite of in-hospital complications and all-cause mortality by day-30
时间窗: Up to 30 days postoperatively
Composite of in-hospital complications and all-cause mortality by day-30, and complications were defined as the serious ones that cause prolonged hospitalization, or life threatening, but could get recovery after intense treatment during hospitalization, or life threatening, resulting in significantly decreased quality of life.
次要结局
- Incidences of in-hospital infectious complications.(Up to 30 days postoperatively)
- Intensive Care Unit (ICU) admission rate(Up to 30 days postoperatively)
- Length of hospital stay (LOS)(Up to 30 days postoperatively)
- Hemoglobin level at different time points(Up to 30 days postoperatively)
- Cost of transfusion and hospitalization(Up to 30 days postoperatively)
- SF-8 questionnaire(Up to one year postoperatively)
- Healing status of surgical incision(Up to 30 days postoperatively)
- All-cause mortality during 1-year after operation(Up to one year postoperatively)
研究者
Ren Liao
Associate Professor
West China Hospital